Provided herein are, inter alia, biological manufacturing and downstream purification processes.

The invention provides novel synthetic antibodies directed against VEGF and uses thereof.

Provided herein are, inter alia, biological manufacturing and downstream purification processes.

Described herein are compositions for delivering single-domain antibodies or antigen-binding fragments thereof to a subject. The single-domain antibodies may be therapeutic agents for treatment of a disease or a condition in the subject, such as a disease or a condition of affecting the lungs of the subject. The compositions comprise enucleated cells that are extensively engineered to produce the single-domain antibodies or antigen-binding fragment thereof, and optionally, contain additional components, such as a targeting moiety, immune system evading moiety, or additional therapeutic agents or adjuvants. Methods of producing the compositions described herein are provided, which involve methods of enucleating a parent cell to obtain the enucleated cell comprising the single-domain antibody or antigen-binding fragment thereof. Also provided are kits and methods for using the compositions described herein to treat the disease or a condition by administering one or more of the compositions to the subject.

Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.

The present invention describes a neurotoxin associated protein from botulinum neurotoxin complex used as an oral or nasal delivery system for a vaccine. The vaccine is selected from tetanus, diphtheria and pertussis alone or in combination. Further the oral or nasal delivery of tetanus vaccine in combination with other drug molecules.

The present invention relates to immunoglobulin (Ig) binding proteins comprising one or more domains having highly hydrophobic amino acids with branched side chains (Iso, Leu, Val), or aromatic amino acids (Tyr, Phe, or Trp) corresponding to position 4 or 6 or 8 of the Ig binding protein of SEQ ID NO: 1 or functionally similar proteins. The novel proteins have superior properties for highly efficient purification methods for antibodies (immunoglobulins), for example, the proteins have high binding capacity and high chemical stability. The invention further relates to affinity matrices comprising the Ig binding proteins of the invention. The invention also relates to a use of these Ig binding proteins or affinity matrices for affinity purification of immunoglobulins and to methods of affinity purification using the Ig binding proteins of the invention.

Provided herein are, inter alia, biological manufacturing and downstream purification processes.

Provided herein are, inter alia, biological manufacturing and downstream purification processes.

Disclosed herein are methods for the isolation and purification of anti-IL-13 antibodies wherein the use of an affinity chromatographic step results in an antibody composition sufficiently pure for pharmaceutical uses. The methods described herein comprise pH viral reduction/inactivation, ultrafiltration/diafiltration, affinity chromatography (e.g., Protein A affinity chromatography), ion exchange chromatography, and hydrophobic chromatography. Further, the present invention is directed toward pharmaceutical compositions comprising one or more antibodies of the present invention.